The adoption of the agreement on NGTs by the European Council marks a key step forward towards a modern, science-based regulatory framework.

On April 21, the Member States of the European Union formally approved their position on the Regulation on New Genomic Techniques (NGTs), confirming their support for a specific framework that distinguishes between two categories of NGT plants and introduces measures on traceability, labelling, and transparency regarding patents. This adoption confirms the consensus within the Council of the European Union on the need for a tailored framework for these techniques and allows the file to move forward to its final stage in the European Parliament.

Although this step is key, the legislative process is not yet complete. The final decision now depends on the European Parliament, which will vote on the text in the coming weeks. According to the current working calendar in Brussels, the text will be reviewed again by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) and subsequently put to a plenary vote, where the final decision is expected on May 18.

If the plenary approves the Regulation, the text will be formally adopted and will move to the implementation phase. The new regulatory framework is expected to enter into force following its official publication in 2026 and to be fully applicable from mid-2028, once the 24-month transitional period required to develop and adapt the corresponding legislation has been completed.

Since its inception, the NGT Regulation has followed an intense path within the European institutions:

Regulatory beginnings and early disagreements and blockages

On July 5, 2023, the European Commission presented the proposal for a Regulation on plants obtained through new genomic techniques, structured into two categories: NGT1 (equivalent to conventional plants) and NGT2 (all other NGT plants).

In October of that year, the ENVI Committee proposed amendments to the draft to clarify definitions and emphasise the scientific basis of verification. On January 24, 2024, ENVI adopted its report on the proposal, thereby supporting the new framework and the distinction between NGT1 and NGT2. This allowed the file to move forward to the European Parliament plenary.

Thus, on February 7, 2024, the European Parliament adopted its first-reading negotiating mandate, introducing a proposed clause requiring the Commission to assess the impact of patents and calling for the exclusion of NGT plants from patentability. This became a key demand to unlock support from agricultural sectors and certain political groups. Two and a half months later, the Parliament plenary confirmed its official position, allowing negotiations with the Council to begin.

Regulatory stagnation and the start of trilogues

With negotiations in the hands of the Council, a prolonged standstill of eleven months followed, driven by concerns from several Member States regarding the coexistence of NGTs with organic farming and patents.

Finally, on March 14, 2025, Member States agreed on a common position on the Regulation, unlocking the file and allowing trilogue negotiations to begin. During this period, 25 organisations across the European Union (EU) signed a joint letter addressed to the European Parliament calling for no unjustified new restrictions and supporting a final agreement consistent with the original spirit of the Commission’s proposal.

Provisional political agreement and technical validation

It was not until the third and final round of negotiations (December 3, 2025), almost two and a half years after the proposal was presented, that negotiators from the three institutions (Commission, Parliament, and Council) reached a political agreement on the final text of the Regulation.

This is considered the key “unblocking” step, as it finalises the technical content of the legislation. The provisional agreement confirms the two categories of NGTs, establishes criteria for NGT1, and sets out a list of excluded traits (such as herbicide tolerance and the production of known insecticidal substances), as well as introducing transparency measures on patents.

Two weeks later, the Member States, meeting in the Committee of Permanent Representatives (COREPER), formally endorsed the agreement reached on December 3. The text received support from 18 countries, representing approximately 66% of the EU. Shortly afterwards, on January 28, 2026, the ENVI Committee voted in favour of the compromise text, validating the trilogue outcome and paving the way for formal adoption.

Final votes and adoption

At this stage, the process enters its final phase. On April 21, the Council formally adopted the Regulation. The ENVI Committee must now issue a technical recommendation vote to the plenary to confirm that the Council text matches the agreed compromise. The final closure will take place at the European Parliament plenary session scheduled for May 18, where the Regulation is expected to be ratified for subsequent publication and entry into force.

At AseBio, we have closely followed this process, advocating for a clear, proportionate, and science-based regulatory framework, as well as the importance of preserving legal certainty and protecting innovation.

What does the Council’s decision imply?

The adoption of the agreement by the Council on April 21 represents a near-final milestone in the legislative process. This decision:

• Reinforces the stability and predictability of the file, allowing the Parliament to proceed towards final votes with a text already agreed by Member States.
• Confirms the EU’s political commitment to a specific regulatory framework for NGTs, capable of addressing the challenges of sustainability, resilience, and competitiveness in the European agri-food system.
• Brings Europe closer to a more agile, science-based regulation that can accelerate innovative solutions for climate adaptation, input reduction, and improved agricultural productivity.
• Activates preparation for the implementation phase, in which technical procedures, verification guidelines, implementing acts, and support mechanisms will be defined to ensure harmonised application across all Member States.

For AseBio, this phase will be crucial to ensure that the Regulation is implemented with technical rigor, proportionality, and legal certainty, avoiding divergences between countries that could affect the Single Market and sector competitiveness.

The Council’s decision comes after nearly three years of technical work, political negotiation, and continuous dialogue between European institutions, the scientific community, breeders, farmers, and representative organisations. This extensive legislative journey reflects the complexity and strategic importance of this Regulation for the future of the European agri-food system.

For AseBio, this process demonstrates a collective effort to build a modern, proportionate, and science-based regulatory framework capable of supporting innovation and addressing Europe’s climate, productivity, and competitiveness challenges. With the final stage of the legislative process now underway, we reaffirm our commitment to continuing to work with European and national institutions to ensure that the implementation of the Regulation consolidates all progress achieved and allows the full potential of NGTs to be harnessed in favour of sustainability, resilience, and the strategic autonomy of the European Union.